Surgical stapler tool assembly to minimize bleeding

ABSTRACT

A cartridge assembly for a surgical stapling device includes a staple cartridge that includes a staple array that has a configuration to minimize blood leakage through a staple line formed by the staple cartridge.

FIELD

This disclosure is generally related to surgical stapling devices and,more particularly, to staple cartridges for use with surgical staplingdevices.

BACKGROUND

Surgical stapling devices for stapling tissue during a surgicalprocedure are well known. Such devices allow a clinician to suturetissue more quickly than traditional suturing techniques to shorten thelength of the surgical procedure and minimize patient trauma. During astapling procedure, a staple line is formed at a surgical site. Bleedingat the surgical site through the staple line is common and may lead toinfection which may cause significant discomfort to the patient.

A continuing need exists in the art for a surgical stapling device thatincludes a tool assembly that forms a staple line that minimizesbleeding at the surgical site.

SUMMARY

In aspects, this disclosure generally relates to a staple cartridge fora surgical stapling device that includes a staple array that has aconfiguration to minimize blood leakage through a staple line formed bythe staple cartridge. One aspect of this disclosure is directed to astaple cartridge including a cartridge body defining a longitudinalaxis, a central knife slot, and three rows of staple pockets on at leastone side of central knife slot. The three rows of staple pockets on theat least one side of the central knife slot include an inner row ofstaple pockets positioned adjacent the central knife slot, an outer rowof staple pockets spaced outwardly of the inner row of staple pockets,and a middle row of staple pockets positioned between the inner andouter rows of staple pockets. The staple pockets in the inner row ofstaple pockets are longitudinally aligned with each other and the staplepockets in the outer row of staple pockets are longitudinally alignedwith each other. Each of the staple pockets in the middle row of staplepockets defines an acute angle with the longitudinal axis of thecartridge body and the orientation of each of the staple pockets in themiddle row of staple pockets alternates in direction along the length ofthe middle row of staple pockets.

In aspects of the disclosure, each of the staple pockets in the innerrow of staple pockets is laterally aligned with one of the staplepockets in the outer row of staple pockets.

In some aspects of the disclosure, the staple pockets in the inner andouter rows of staple pockets are alternatingly positioned along thelongitudinal axis of the cartridge body such that the staple pockets inthe inner row of staple pockets are not laterally aligned with any ofthe staple pockets in the outer row of staple pockets.

In certain aspects of the disclosure, each of the staple pocketssupports a staple.

In aspects of the disclosure, adjacent staple pockets in the inner,middle, and outer rows of staple pockets define a trapezoidalconfiguration that is configured to redirect blood flow away from theinner row of staple pockets.

In some aspects of the disclosure, the cartridge body supports abuttress material.

In certain aspects of the disclosure, the staple pockets in the middlerow of staple pockets define a sinusoidal configuration along thelongitudinal axis of the cartridge body.

Other aspects of the disclosure are directed to a tool assemblyincluding an anvil assembly and a cartridge assembly. The cartridgeassembly is supported in relation to the anvil assembly to facilitatemovement of the tool assembly between an open position and a clampedposition. The cartridge assembly includes a cartridge channel and astaple cartridge that is received within the cartridge channel. Thestaple cartridge includes a cartridge body defining a longitudinal axis,a central knife slot, and three rows of staple pockets on at least oneside of central knife slot. The three rows of staple pockets on the atleast one side of the central knife slot include an inner row of staplepockets positioned adjacent the central knife slot, an outer row ofstaple pockets spaced outwardly of the inner row of staple pockets, anda middle row of staple pockets positioned between the inner and outerrows of staple pockets. The staple pockets in the inner row of staplepockets are longitudinally aligned with each other and the staplepockets in the outer row of staple pockets are longitudinally alignedwith each other. Each of the staple pockets in the middle row of staplepockets defines an acute angle with the longitudinal axis of thecartridge body and the orientation of each of the staple pockets in themiddle row of staple pockets alternates in direction along the length ofthe middle row of staple pockets.

Other aspects of the disclosure are directed to surgical staplingdevices including a handle assembly, an elongate body, and a toolassembly. The elongate body has a proximal end coupled to the handleassembly and a distal end. The tool assembly is supported on the distalend of the elongate body and includes an anvil assembly and a cartridgeassembly. The cartridge assembly is supported in relation to the anvilassembly to facilitate movement of the tool assembly between an openposition and a clamped position. The cartridge assembly includes acartridge channel and a staple cartridge that is received within thecartridge channel The staple cartridge includes a cartridge bodydefining a longitudinal axis, a central knife slot, and three rows ofstaple pockets on at least one side of the central knife slot. The threerows of staple pockets on the at least one side of the central knifeslot include an inner row of staple pockets positioned adjacent thecentral knife slot, an outer row of staple pockets spaced outwardly ofthe inner row of staple pockets, and a middle row of staple pocketspositioned between the inner and outer rows of staple pockets. Thestaple pockets in the inner row of staple pockets are longitudinallyaligned with each other and the staple pockets in the outer row ofstaple pockets are longitudinally aligned with each other. Each of thestaple pockets in the middle row of staple pockets defines an acuteangle with the longitudinal axis of the cartridge body and theorientation of each of the staple pockets in the middle row of staplepockets alternates in direction along the length of the middle row ofstaple pockets.

Other features of the disclosure will be appreciated from the followingdescription.

BRIEF DESCRIPTION OF DRAWINGS

Various aspects of the disclosure are described herein below withreference to the drawings, wherein:

FIG. 1 is a perspective view of a surgical stapling device having astaple cartridge including aspects of the disclosure;

FIG. 2 is an enlarged view of the indicated area of detail shown in FIG.1;

FIG. 2A is a top perspective view of the staple cartridge of thesurgical stapling device shown in FIG. 1;

FIG. 2B is a side perspective view of a staple of the staple cartridgeshown in FIG. 2A;

FIG. 3 is a top view of the staple cartridge of the surgical staplingdevice shown in FIG. 1;

FIG. 4 is a top view of tissue with a buttress material secured to thetissue after the tissue is cut with the stapling device of FIG. 1;

FIG. 4A is an enlarged view of the indicated area of detail shown inFIG. 4;

FIG. 5 is a cutaway view of the tissue and buttress material shown inFIG. 4; and

FIG. 6 is an alternative staple cartridge of the surgical staplingdevice shown in FIG. 1.

DETAILED DESCRIPTION

The disclosed staple cartridge for use with a surgical stapling devicewill now be described in detail with reference to the drawings in whichlike reference numerals designate identical or corresponding elements ineach of the several views. However, it is to be understood that theaspects of the disclosure are merely exemplary of the disclosure and maybe embodied in various forms. Well-known functions or constructions arenot described in detail to avoid obscuring the disclosure in unnecessarydetail. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the disclosure in virtually any appropriatelydetailed structure. In addition, directional terms such as front, rear,upper, lower, top, bottom, distal, proximal, and similar terms are usedto assist in understanding the description and are not intended to limitthe disclosure.

In this description, the term “proximal” is used generally to refer tothat portion of the device that is closer to a clinician, while the term“distal” is used generally to refer to that portion of the device thatis farther from the clinician. In addition, the term “endoscopic” isused generally used to refer to endoscopic, laparoscopic, arthroscopic,and/or any other procedure conducted through a small diameter incisionor cannula. Further, the term “clinician” is used generally to refer tomedical personnel including doctors, nurses, and support personnel.

FIG. 1 illustrates the disclosed surgical stapling device showngenerally as stapling device 10 which includes a handle assembly 12, anelongate body 14, and a tool assembly 100. Although not described indetail herein, the tool assembly 100 can form part of a reload assembly16 that is releasably coupled to the elongate body 14 and includes aproximal body portion 16 a and the tool assembly 100. Alternately, thetool assembly 100 can be fixedly secured to a distal portion of theelongate body 14.

The elongate body 14 defines a longitudinal axis “X”. The handleassembly 12 includes a body 18 defining hand grip 18 a, a plurality ofactuator buttons 20, and a rotation knob 22. The rotation knob 22 isrotatably supported on a distal portion of the body 18 of the handleassembly 12 and supports the elongate body 14 to facilitate rotation ofthe elongate body 14 and the tool assembly 100 in relation to the handleassembly 12 about the longitudinal axis “X”. The actuator buttons 20control operation of the various functions of the stapling device 10including approximation, firing and cutting. Although the staplingdevice 10 is illustrated as an electrically powered stapling device, itis envisioned that the disclosed tool assembly 100 would also besuitable for use with a manually powered surgical stapling device. U.S.Pat. No. 9,055,943 (the '943 Patent) discloses a surgical staplingdevice including a powered handle assembly and U.S. Pat. No. 6,241,139(the '139 Patent) discloses a manually actuated handle assembly. For amore detailed description of exemplary a handle assembly and elongatebody 14 of the stapling device 10, see, e.g., the '943 and '139 Patents.

FIGS. 2-3 illustrate the tool assembly 100 of the stapling device 10.The tool assembly 100 defines a longitudinal axis “Y” and includes ananvil assembly 112 and a cartridge assembly 114. The anvil assembly 112and the cartridge assembly 114 are movable in relation to each otherbetween an open or spaced position (FIG. 2) and a clamped position. Theanvil assembly 112 includes a staple deforming surface 116 that definesa plurality of staple deforming pockets (not shown). In aspects of thedisclosure, the anvil assembly 112 and the cartridge assembly 114support a buttress material 120 that reinforces a staple line “SL” (FIG.4) that is formed in tissue “T” as described below. For a detaileddescription of exemplary aspects of the anvil assembly 112, see the '139Patent.

The cartridge assembly 114 includes a cartridge channel 130 and a staplecartridge 132. The cartridge channel 130 receives and supports thestaple cartridge 132. In aspects of the disclosure, the staple cartridge132 is removable from the cartridge channel 130 to facilitate reuse ofthe stapling device 10. Alternately, the staple cartridge 132 is fixedlysecured within the cartridge channel 130 and the reload 16 can beremoved from the stapling device 10 to facilitate reuse of the staplingdevice 10.

The staple cartridge 132 includes a cartridge body 140 that defines acentral knife slot 141 and a plurality of staple receiving pockets 142.The staple receiving pockets 142 are aligned in three rows on each sideof the central knife slot 141 including an inner row 144, a middle row146, and an outer row 148. Each of the staple receiving pockets 142supports a staple 150 (FIG. 2B). In aspects of the disclosure, thestaple pockets 142 in the inner rows 144 and the outer rows 148 defineaxes that are parallel to the longitudinal axis “Y” of the tool assembly100. In some aspects of the disclosure, each of the staple pockets 142in the inner rows 144 of staple pockets 142 is laterally aligned with astaple pocket 142 in the outer rows 148 of staple pockets 142. In otheraspects of the disclosure, each of the staple pockets 142 in the middlerows 146 of staple pockets 142 defines an acute angle with thelongitudinal axis “Y” of the tool assembly 100 and has an orientationthat alternates in direction along the length of the middle rows 146 ofstaple pockets 142, i.e., the direction of axes defined by the staplepockets 142 in the middle row 146 of staple pockets 142 alternates backand forth along the length of the middle row 146 of staple pockets 142to define, if joined by an imaginary line connecting end of the staplepockets 142 in the middle row, a substantially sinusoidal curve“SC”(FIG. 5). In this aspect of the disclosure, two adjacent staplepockets 142 in the middle row 146 of staple pockets 142 and the adjacentstaple pockets 142 in the inner and outer rows 144 and 148 of staplepockets 142 define a substantially trapezoidal configuration “TR” (FIG.4A).

FIG. 2B illustrates one of the staples 150 of the staple cartridge 132.Each of the staples 150 includes a back span 152 and a pair of legs 154that extend from opposite sides of the back span 152. Each of the legs154 includes a tapered tip 156 that is configured to pierce tissue “T”and the buttress materials 120. As described above, the staples 150 arereceived with respective staple pockets 142 of the staple cartridge 132such that the back span 152 of each of the staples 150 defines an axisthat is longitudinally aligned with the axis of the staple pocket 142 inwhich the staple 150 is received.

FIGS. 4 and 5 illustrate the staples 150 formed in the tissue “T” withthe tissue cut along a cut line 160. The staples 150 in the rows ofstaples 150 define staple lines “SL” (FIG. 4) on each side of the cutline 160 in the tissue “T”. As shown, when the staples 150 of the staplecartridge 132 are formed in the tissue “T”, adjacent staples 150 in theinner rows 144, the middle rows 146, and outer rows 148 of staples 150define trapezoidal configurations that are aligned along the staple line“SL” (FIG. 4).

When staples 150 are formed in tissue “T” along the cutline 160, bloodflow from an organ side “OS” of the tissue “T” flows towards the cutline160. The major path or leakage to occur is through staple line “SL”through gaps between the staples 150. This leakage may result inhematoma and infection and also cause poor visibility at a surgicalsite. The poor visibility must be addressed by a clinician, such as byclearing the leakage from the surgical site with a cloth which maylengthen the duration of the surgical procedure and increase the rate ofoccurrence of infection.

In the disclosed staple cartridge 132, the staples 150 are positioned insuch a way that blood flow from the organ side “OS” of the tissue “T”that passes through the outer row 148 of the staples 150 is directedback towards the organ side “OS” of the tissue “T” in the direction ofarrow “A” in FIG. 5 by the orientation of the middle rows 146 and innerrows 144 of staples 150. In this manner, the configuration of the stapleline “SL” when formed in tissue “T” minimizes the amount of bloodleakage through the staple line “SL”.

FIG. 6 illustrates an alternate staple line “SL2” configuration.Although not shown, the staple cartridge used to form this staple line“SL2” includes staple pockets having an orientation substantiallyidentical to the orientation of the staples 250 in the staple line“SL2”. The staple line “SL2” is substantially the same as the stapleline “SL” (FIG. 5) except that every other staple 250 in the inner andouter rows 244 and 248 of staples 250 is removed such that the staples250 in the inner and outer rows 244 and 248 are alternatingly positionedalong the staple line “SL2” and are laterally offset from each other. Inthis configuration, the staples 250 in the inner and middle rows 244 and246 of staples 250 define a substantially trapezoidal configuration inthe form of trapezoidal buckets 251 with one of the parallel sides ofthe trapezoid removed. The trapezoidal buckets 251 direct blood flow inthe direction of arrow “B” back towards the organ side of the tissue “T”to minimize blood leakage from the staple line “SL2”.

It is envisioned that a staple cartridge in accordance with thisdisclosure may include one of the staple pocket configurations describedabove on only one side of the central knife slot 141 (FIG. 3) and atraditional staple pocket configuration on the other side of the centralknife slot 141, e.g., two or three longitudinally aligned rows ofstaples. A staple cartridge having this configuration could be usedduring surgical procedures in which tissue is being removed from apatient such as a colectomy procedure. In such a procedure, the toolassembly 100 of the stapling device 10 would be oriented to place thestaple line “SL” or “SL2” on the organ side “OS” of the tissue “T” andto place the staple line having the traditional configuration on thetissue to be removed from the patient.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary aspects of the disclosure. It isenvisioned that the elements and features illustrated or described inconnection with one exemplary embodiment may be combined with theelements and features of another without departing from the scope of thepresent disclosure. As well, one skilled in the art will appreciatefurther features and advantages of the disclosure based on theabove-described aspects of the disclosure. Accordingly, the disclosureis not to be limited by what has been particularly shown and described,except as indicated by the appended claims.

What is claimed is:
 1. A staple cartridge comprising: a cartridge bodydefining a longitudinal axis, a central knife slot, and three rows ofstaple pockets on at least one side of central knife slot, the threerows of staple pockets on the at least one side of the central knifeslot including an inner row of staple pockets positioned adjacent thecentral knife slot, an outer row of staple pockets spaced outwardly ofthe inner row of staple pockets, and a middle row of staple pocketspositioned between the inner and outer rows of staple pockets, thestaple pockets in the inner row of staple pockets being longitudinallyaligned with each other and the staple pockets in the outer row ofstaple pockets being longitudinally aligned with each other, whereineach of the staple pockets in the middle row of staple pockets definesan acute angle with the longitudinal axis of the cartridge body and theorientation of each of the staple pockets in the middle row of staplepockets alternates in direction along the length of the middle row ofstaple pockets.
 2. The staple cartridge of claim 1, wherein each of thestaple pockets in the inner row of staple pockets is laterally alignedwith one of the staple pockets in the outer row of staple pockets. 3.The staple cartridge of claim 1, wherein the staple pockets in the innerand outer rows of staple pockets are alternatingly positioned along thelongitudinal axis of the cartridge body such that the staple pockets inthe inner row of staple pockets are not laterally aligned with any ofthe staple pockets in the outer row of staple pockets.
 4. The staplecartridge of claim 1, wherein each of the staple pockets supports astaple.
 5. The staple cartridge of claim 1, wherein adjacent pockets inthe inner, middle, and outer rows of staple pockets define a trapezoidalconfiguration that is configured to redirect blood flow away from theinner row of staple pockets.
 6. The staple cartridge of claim 1, whereinthe cartridge body supports a buttress material.
 7. The staple cartridgeof claim 1, wherein the staple pockets in the middle row of staplepockets define a sinusoidal configuration along the longitudinal axis ofthe cartridge body.
 8. A tool assembly comprising: an anvil assembly;and a cartridge assembly supported in relation to the anvil assembly tofacilitate movement of the tool assembly between an open position and aclamped position, the cartridge assembly including a cartridge channeland a staple cartridge that is received within the cartridge channel,the staple cartridge including a cartridge body defining a longitudinalaxis, a central knife slot, and three rows of staple pockets on at leastone side of central knife slot, the three rows of staple pockets on theat least one side of the central knife slot including an inner row ofstaple pockets positioned adjacent the central knife slot, an outer rowof staple pockets spaced outwardly of the inner row of staple pockets,and a middle row of staple pockets positioned between the inner andouter rows of staple pockets, the staple pockets in the inner row ofstaple pockets being longitudinally aligned with each other and thestaple pockets in the outer row of staple pockets being longitudinallyaligned with each other, wherein each of the staple pockets in themiddle row of staple pockets defines an acute angle with thelongitudinal axis of the cartridge body and the orientation of each ofthe staple pockets in the middle row of staple pockets alternates indirection along the length of the middle row of staple pockets.
 9. Thetool assembly of claim 8, wherein each of the staple pockets in theinner row of staple pockets is laterally aligned with one of the staplepockets in the outer row of staple pockets.
 10. The tool assembly ofclaim 8, wherein the staple pockets in the inner and outer rows ofstaple pockets are alternatingly positioned along the longitudinal axisof the cartridge body such that the staple pockets in the inner row ofstaple pockets are not laterally aligned with any of the staple pocketsin the outer row of staple pockets.
 11. The tool assembly of claim 8,wherein each of the staple pockets supports a staple.
 12. The toolassembly of claim 8, wherein adjacent pockets in the inner, middle, andouter rows of staple pockets define a trapezoidal configuration that isconfigured to redirect blood flow away from the inner row of staplepockets. The tool assembly of claim 8, wherein the cartridge bodysupports a buttress material.
 14. The tool assembly of claim 8, whereinthe staple pockets in the middle row of staple pockets define asinusoidal configuration along the longitudinal axis of the cartridgebody.
 15. A surgical stapling device comprising: a handle assembly; anelongate body having a proximal end coupled to the handle assembly and adistal end; and a tool assembly supported on the distal end of theelongate body, the tool assembly including an anvil assembly and acartridge assembly, the cartridge assembly supported in relation to theanvil assembly to facilitate movement of the tool assembly between anopen position and a clamped position, the cartridge assembly including acartridge channel and a staple cartridge that is received within thecartridge channel, the staple cartridge including a cartridge bodydefining a longitudinal axis, a central knife slot, and three rows ofstaple pockets on at least one side of the central knife slot, the threerows of staple pockets on the at least one side of the central knifeslot including an inner row of staple pockets positioned adjacent thecentral knife slot, an outer row of staple pockets spaced outwardly ofthe inner row of staple pockets, and a middle row of staple pocketspositioned between the inner and outer rows of staple pockets, thestaple pockets in the inner row of staple pockets being longitudinallyaligned with each other and the staple pockets in the outer row ofstaple pockets being longitudinally aligned with each other, whereineach of the staple pockets in the middle row of staple pockets definesan acute angle with the longitudinal axis of the cartridge body and theorientation of each of the staple pockets in the middle row of staplepockets alternates in direction along the length of the middle row ofstaple pockets.
 16. The surgical stapling device of claim 15, whereineach of the staple pockets in the inner row of staple pockets islaterally aligned with one of the staple pockets in the outer row ofstaple pockets.
 17. The surgical stapling device of claim 15, whereinthe staple pockets in the inner and outer rows of staple pockets arealternatingly positioned along the longitudinal axis of the cartridgebody such that the staple pockets in the inner row of staple pockets arenot laterally aligned with any of the staple pockets in the outer row ofstaple pockets.
 18. The surgical stapling device of claim 15, each ofthe staple pockets supports a staple.
 19. The surgical stapling deviceof claim 15, adjacent pockets in the inner, middle, and outer rows ofstaple pockets define a trapezoidal configuration that is configured toredirect blood flow away from the inner row of staple pockets.
 20. Thesurgical stapling device of claim 15, wherein the staple pockets in themiddle row of staple pockets define a sinusoidal configuration along thelongitudinal axis of the cartridge body.